Data published in the February 2000 and August 2002 issues of Experimental and Molecular Pathology strongly suggests that Gulf War Syndrome is caused by a vaccine contaminated with squalene.

The August 2002 article is entitled "Antibodies to Squalene in Recipients of Anthrax Vaccine" (Exp. Mol. Pathol. 73,19-27 (2002)).

Gulf War Syndrome, or GWS, is the term which has been applied to the multi-symptom rheumatic disorder experienced by many veterans of the 1990-1991 Persian Gulf war. A similar disorder appeared in 1990-1991-era personnel who were never deployed to the Persian Gulf theater of operations and also in other military personnel, including participants in the Anthrax Vaccine Immunization Program, or AVIP, which was inaugurated in 1997. No data has ever suggested that the disorder experienced by the deployed 1990-1991 soldiers is different from the disorder experienced by the other groups of patients, but the other cases have not been considered to be cases of GWS.

Squalene was found by the U.S. Food and Drug Administration in five lots of the AVIP anthrax vaccine. The discovery of serum anti-squalene antibodies and the development of a test to detect these antibodies has made it possible to see that links appear to exist between the contaminated AVIP vaccine lots, the illness experienced by post-1997 vaccine recipients, the illness experienced by non-deployed 1990-1991-era patients, and the illness in deployed 1990-1991-era patients that has been referred to as GWS.

The data establishing these links is presented in the peer-reviewed February 2000 and August 2002 articles. The published findings (1) strongly suggest that the GWS-like illness being reported by all of the various patient groups is the same illness, (2) strongly suggest that the contaminated vaccine caused the illness in the AVIP group, and (3) further suggest that squalene contamination of one or more 1990-1991-era vaccines accounts for the GWS cases from that era.

Before the anti-squalene antibody test was developed, there was no specific laboratory test for GWS. Both articles suggest that the antibodies can serve as an excellent laboratory marker to help identify patients with GWS. Using the antibodies as a laboratory marker for GWS could be very useful in helping physicians diagnose the disorder and in differentiating it from other rheumatic illnesses.

Anti-squalene antibodies might also provide a key to more effectively treating GWS patients. The presence of the antibodies in GWS patients indicates that the immune system is involved in the development of GWS. Effective drugs which modulate the human immune system are already in wide use, but they have not been previously considered to be appropriate for GWS patients. The published data now suggests that the use of immune modulators in GWS patients should be studied.

In March 1999, the United States General Accounting Office
(the GAO) encouraged the Department of Defense to investigate
the discovery of anti-squalene antibodies. In GAO/NSIAD-99-5,
"Gulf War Illnesses - Questions About the Presence of
Squalene Antibodies in Veterans Can Be Resolved," the
GAO urged the DoD to conduct its own research into anti-squalene
antibodies with two objectives in mind: (1) to confirm
the existence of the newly-discovered antibodies, and
(2) to acquire patient data, explore the apparent link
between the antibodies and the illness in GWS patients,
and attempt to confirm or disprove the existence of such
a link. Click on GAO/NSIAD-99-5
for a PDF version of this report. See
Notes on PDF Files if you would like help with
the PDF format.

To satisfy the first GAO objective, the Army researchers confirmed that anti-squalene antibodies do indeed exist and can reliably be detected. They published their findings in an article entitled "Induction and Detection of Antibodies to Squalene," which appeared in the November 2000 issue of the Journal of Immunological Methods (J Immunol Methods 2000 Nov 1;245(1-2):1-14). The Army researchers conducted their testing by applying squalene to the wells of ELISA plates. Dr. Robert F. Garry, the Tulane Medical School professor who discovered anti-squalene antibodies and developed the test for detecting them, and his colleagues conducted their testing for the February 2000 and August 2002 articles by applying squalene to nitrocellulose strips in a Western-blot-type assay. There is no material difference between the two test methods, and both are covered by the patent which subsequently issued to Tulane.

Although the Army researchers confirmed the validity of
the test and thus added support to the February 2000 patient
data, their November 2000 article included no patient
data of its own and as a result did not specifically address
the GAO's second objective. The Army researchers also
failed to embrace the peer-reviewed February 2000 data
itself, as is discussed in the statement submitted by
Dr. Garry to the House Subcommittee on National Security,
Veterans Affairs and International Relations for the record
of its hearing into Gulf War illnesses on January 24,
2002. Dr. Garry's statement can be seen on the Subcommittee's
Web site on the Autoimmune Technologies Web site at Garry 24 Jan
2002 House Subcommittee Statement.

Tulane has licensed the anti-squalene antibody technology to Autoimmune Technologies. U.S. Patent No. 6,214,566 covering the anti-squalene antibody test, which the Company calls the Anti-Squalene Antibody Assay or ASA Assay, was awarded to Tulane in April 2001. Because this patent covers the method which was used by the Army researchers to verify the existence of the antibodies, Autoimmune Technologies has offered the ASA Assay technology to the Department of Defense for use in conducting a large confirmatory study of the patient data in the February 2000 and August 2002 articles. The Company has urged the DoD to sponsor such a study.